Ursodex
Generic Name
Ursodeoxycholic Acid
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ursodex 150 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Ursodeoxycholic Acid (UDCA) is a naturally occurring bile acid used to dissolve cholesterol gallstones, treat primary biliary cholangitis (PBC), and manage certain other hepatobiliary disorders.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day in 2-3 divided doses. For PBC: 13-15 mg/kg/day in 2-4 divided doses.
Elderly
No specific dosage adjustment required, but monitor for adverse effects.
Renal_impairment
No specific dose adjustment required; not significantly renally excreted.
How to Take
Oral administration, usually with food. For gallstone dissolution, a single evening dose or bedtime dose is often preferred. For PBC, it is usually taken in divided doses.
Mechanism of Action
UDCA reduces the cholesterol saturation of bile by inhibiting hepatic cholesterol synthesis and secretion, which leads to the dissolution of cholesterol gallstones. It also has cytoprotective, anti-inflammatory, and immunomodulatory effects on the liver.
Pharmacokinetics
Onset
Variable; gallstone dissolution can take months. Clinical improvement in PBC may be seen over weeks to months.
Excretion
Primarily excreted in feces via bile.
Half life
Approximately 3-6 hours.
Absorption
Well absorbed orally (approximately 90%), but undergoes significant first-pass metabolism.
Metabolism
Undergoes enterohepatic recirculation; conjugated in the liver and partially degraded by intestinal bacteria.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation
- Acute inflammation of the gallbladder or bile ducts (acute cholecystitis, cholangitis)
- Obstruction of the biliary tract (e.g., common bile duct obstruction)
- Frequent episodes of biliary colic
- Non-cholesterol or calcified gallstones
- Impaired contractility of the gallbladder
Drug Interactions
Dapsone
UDCA may reduce the absorption of dapsone.
Ciclosporin
UDCA may increase the absorption of ciclosporin. Monitor ciclosporin levels.
Clofibrate, Estrogens, Oral Contraceptives
May increase hepatic cholesterol secretion and gallstone formation, counteracting the effects of UDCA.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
These agents bind bile acids and reduce the absorption of UDCA. Should be taken at least 2 hours apart.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
The main symptom of overdose is diarrhea. Treatment is symptomatic and supportive, with no specific antidote.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if clearly needed and the potential benefits outweigh the potential risks. UDCA is excreted in breast milk in very low amounts; caution is advised during breastfeeding. Consult your doctor.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any component of the formulation
- Acute inflammation of the gallbladder or bile ducts (acute cholecystitis, cholangitis)
- Obstruction of the biliary tract (e.g., common bile duct obstruction)
- Frequent episodes of biliary colic
- Non-cholesterol or calcified gallstones
- Impaired contractility of the gallbladder
Drug Interactions
Dapsone
UDCA may reduce the absorption of dapsone.
Ciclosporin
UDCA may increase the absorption of ciclosporin. Monitor ciclosporin levels.
Clofibrate, Estrogens, Oral Contraceptives
May increase hepatic cholesterol secretion and gallstone formation, counteracting the effects of UDCA.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
These agents bind bile acids and reduce the absorption of UDCA. Should be taken at least 2 hours apart.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
The main symptom of overdose is diarrhea. Treatment is symptomatic and supportive, with no specific antidote.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if clearly needed and the potential benefits outweigh the potential risks. UDCA is excreted in breast milk in very low amounts; caution is advised during breastfeeding. Consult your doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from the manufacturing date, depending on specific manufacturer guidelines.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have established the efficacy and safety of Ursodeoxycholic Acid in dissolving cholesterol gallstones and managing primary biliary cholangitis.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) should be monitored at regular intervals (e.g., every 3-6 months), especially during the first year of treatment.
- Ultrasound of the gallbladder for gallstone size and dissolution progress (every 6-12 months).
Doctor Notes
- Emphasize the importance of patient adherence for the extended treatment duration required for gallstone dissolution.
- Regular monitoring of liver function tests is crucial, especially in PBC patients.
- Caution should be exercised in patients with complete biliary obstruction, as UDCA is contraindicated in such cases.
Patient Guidelines
- Take Ursodex exactly as prescribed by your doctor.
- Do not stop treatment without consulting your doctor, even if you feel better.
- For gallstone dissolution, treatment can be long-term (up to 2 years).
- Report any severe diarrhea or abdominal pain to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.
Driving Precautions
Ursodex generally does not affect the ability to drive or operate machinery. However, if you experience dizziness, avoid driving or performing tasks that require alertness.
Lifestyle Advice
- Maintain a healthy, balanced diet and lifestyle.
- Avoid rapid weight loss as it can contribute to gallstone formation or recurrence.
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